In this story, we’ll explain what we know about the financial and conflict-of-interest disclosure requirements for Dr. Anthony Fauci, other National Institutes of Health higher-ups and members of two U.S. vaccine advisory committees.
The topic came up during a Senate hearing in June, when Republican Sen. Rand Paul of Kentucky questioned Fauci, director of the National Institute of Allergy and Infectious Diseases, about royalties paid to NIH and NIH inventors from third parties who have licensed NIH patents or inventions.
What do NIH officials have to disclose?
The NIH is one of several agencies within the U.S. Department of Health and Human Services, and the NIH itself is made up of 27 institutes and centers that conduct medical research, including the NIAID, which Fauci has directed since 1984.
Each year, Fauci and other high-ranking NIH officials are among the many federal employees required to submit a public financial disclosure report (OGE Form 278e) to their employing agency or department. Less senior officials who do not meet the pay or classification requirements for public disclosure submit a confidential report.
In 2020, the Office of Government Ethics, which oversees the financial disclosure program for employees of the executive branch, reported that nearly 27,000 people were required to submit the public report disclosing information about the assets, income and other personal financial interests of the filer, the filer’s spouse and any dependent children.
The Congressional Research Service has explained that the reports filed by “the most senior officials in the executive branch — the President, Vice President, and appointees and nominees to positions classified at Level I and Level II of the Executive Schedule — are available directly from the OGE website.” However, for NIH officials such as Fauci, the public financial disclosures are only available upon request.
In January, we wrote about the multistep process we followed to obtain one of Fauci’s reports, which required emailing the federal health department at Ethics.FinancialDisclosure@hhs.gov, and then completing and submitting OGE Form 201 to the National Institutes of Health’s FOIA office at firstname.lastname@example.org. It took us one business day to receive a redacted version of Fauci’s 42-page report that covered his financial activity for 2019, which was the most recent report available at the time.
But the response time varies, based on the accounts of others who have requested the same documents from NIH.
What does not have to be disclosed?
Federal laws enacted in the 1980s authorize government agencies, including the NIH, to license their inventions to third parties in exchange for royalties that can be used to fund additional research. A statutory formula determines the portion of the royalties that NIH institutes and centers have to share with the NIH employee, or former employee, listed as the inventor.
As Fauci indicated in his response to Paul, he and other NIH officials who must submit the financial disclosure report are not required to include details about royalty payments they have received for products or treatments they developed for the government.
“NIH inventors that receive royalties in the performance of their government duties do not have to disclose such royalties on their financial disclosure reports because they are considered income from the government,” the NIH said in a statement emailed to FactCheck.org. “If the NIH researcher is receiving royalty payments from a non-government institution where they may have worked previously, those royalties are required to be reported in financial disclosure forms and reviewed by NIH Ethics officials.”
NIH told us that it has a policy requiring the hundreds of researchers or investigators in its Intramural Research Program, including Fauci, to notify an NIH Institutional Review Board if the researcher is a recipient of government royalties related to clinical research.
“The NIH IRB will then determine whether additional measures are required to protect human subjects,” the NIH said. Those measures may include “disclosure of government royalty rights related to this research in the informed consent document, or if other circumstances exist in which there may be a financial conflict of interest, a statement that an actual or apparent conflict of interest may exist.”
What information about NIH royalties is publicly available?
Comprehensive information about royalties paid to the NIH and NIH inventors is not available online nor is it readily accessible by the public. On its website, the NIH publishes limited information about the payments, such as the total amounts received by the NIH and other agencies by fiscal year, as well as how those yearly amounts were divided between the NIH and its employee-inventors.
In FY 2021, for example, the NIH received more than $108 million in royalities and NIH inventors received a little over $11 million, according to NIH figures.
More detailed information is hard to come by, even for organizations that file requests under the Freedom of Information Act.
In early May, OpenTheBooks.com, a self-described government watchdog organization, said it had to pursue legal action to get the NIH to release thousands of pages of documents on royalties paid to the agency. But the group said the documents it has received thus far — covering royalties paid between September 2009 and September 2014 — were heavily redacted, excluding important information about which parties paid the royalties, which inventions the royalties were for, and the individual amounts paid to the NIH inventors.
But the redactions are necessary, the NIH has argued.
In another emailed statement, the agency said: “Detailed information about royalties received by NIH and NIH inventors named on [U.S. government] owned patents is considered Confidential Commercial Information and is appropriately withheld from disclosure under FOIA exemptions 3 and 4.” Exemption 3 allows for the withholding of information prohibited from disclosure by another federal law, and Exemption 4 protects trade secrets and commercial or financial information obtained that is privileged or confidential.
In a 2020 report, the Government Accountability Office recommended that the NIH provide more information to the public about the licensing of its intellectual property.
What are the requirements to serve on the CDC’s Advisory Committee on Immunization Practices?
The Advisory Committee on Immunization Practices is a federal advisory committee with 15 voting members, eight members from federal agencies related to immunization programs and 30 liaison representatives from professional organizations. The committee writes recommendations for the administration of vaccines for adults and children, and provides advice and guidance to the Centers for Disease Control and Prevention on vaccine safety.
Members of federal advisory committees, such as the ACIP, are considered Special Government Employees. That is, employees of the executive branch appointed to perform services for a limited amount of time. SGEs are required to file financial disclosure statements and are subject to federal law (18 U.S.C. §208) that prohibits them from participating “in matters in which, to their knowledge, they, their spouse, minor child, or organization has a financial interest.”
According to the committee’s policies and procedures document, ACIP members need to consent to these requirements during their four-year term:
ACIP Policies and Procedures, June 2022
- No member, his or her spouse, or a member of his or her immediate family can be directly employed by a vaccine manufacturer or its parent company.
- Members cannot hold stock in any vaccine manufacturer or its parent company in excess of the OGE de minimus amounts [threshold values established by the OGE]. Members also agree that they, their spouse and minor children will not purchase such stock during their tenure on the committee.
- Members cannot be holders of or otherwise be entitled to royalties or other compensation for a patent on a vaccine product or process, immunologic agent, adjunct or preservative that can be used for a vaccine that may come before ACIP during the anticipated term of appointment under consideration.
- Members agree to resign any advisory or consulting roles, whether paid or unpaid, to a vaccine manufacturer (except participation in clinical trials or service on data monitoring boards) and to forego such consultation or membership on any vaccine manufacturer advisory committees (except participation in clinical trials or service on data monitoring boards), during his/her tenure on ACIP.
- Members forego solicitation or acceptance of funds from vaccine manufacturers on behalf of themselves or others.
- During their tenure on ACIP, members do not serve as a paid litigation consultant or expert witness in litigation involving a vaccine manufacturer.
- Members do not accept honoraria or travel reimbursement with a funding source from a vaccine manufacturer for attendance at scientific meetings, with the exception that they may receive travel reimbursement for CME [Continuing Medical Education] presentations where the source of funding is an unrestricted grant to the CME provider by a vaccine manufacturer.
What do they have to disclose?
ACIP voting members are required to file an annual financial disclosure statement with the Office of Government Ethics.
The report — OGE form 450 — is confidential and must include assets greater than $1,000 for the member, spouse and dependent children; sources of earned income, honoraria and other non-investment income for the preceding 12 months; liabilities that exceeded $10,000 for the member, spouse and dependent children as of the date of filing; all positions held during the last year, and agreements and arrangements with former or future employers as of the date of filing. Those renewing a disclosure report are also required to disclose gifts and travel reimbursements over $166 and totaling more than $415 from “any one source” for themselves, their spouses and dependent children.
The CDC can “determine whether the need for the individual’s services outweighs the potential for conflicts of interest created by the financial interests involved” and issue limited waivers, in accordance with regulations by the OGE. According to ACIP’s policies, limited waivers “generally allow members to fully participate in committee discussions related to waived interests, with the condition that they will be prohibited from voting on such matters.”
Is it publicly available?
As we said, ACIP members’ financial disclosure statements are confidential, unlike those required for more senior officials in the executive branch, which are public.
But voting ACIP members are required to publicly disclose “all vaccine-related interests and work, including participation in clinical trials” at the opening of each meeting and prior to any vote. The ACIP holds three regular public meetings each year, plus emergency sessions. The public can view videos of those meetings, going back to June 2013 on the ACIP channel on YouTube.
According to the CDC, at several meetings during the coronavirus pandemic one ACIP member, Dr. Wilbur Chen, disclosed that his institution, the University of Maryland, received support from Emergent BioSolutions for the development of a different vaccine (shigella). Emergent is a biotechnology company based in Maryland that ruined millions of COVID-19 vaccine doses at a manufacturing plant because of cross-contamination. “This was disclosed although was not determined to be a conflict,” the CDC told us in an email.
What about royalties?
As we said, one of the conditions of ACIP membership is that members can’t be holders of or entitled to royalties or compensation for a patent for vaccine products or processes that “may come” before the ACIP during their tenure. And although a waiver could be granted if the need of a member’s services outweighs the potential conflict of interest, the CDC told us that it “has not provided a waiver based on a patent since these policies and procedures were first drafted over 20 years ago.”
What about the FDA’s Vaccines and Related Biological Products Advisory Committee?
The Vaccines and Related Biological Products Advisory Committee is one of 31 committees used by the Food and Drug Administration to get independent expert advice on different issues. The VRBPAC, composed of 15 voting members, reviews and evaluates data on the safety and effectiveness of vaccines and other biological products intended to prevent, treat or diagnose diseases.
The FDA privately screens members of all advisory committees before every meeting, requiring them to provide information of their financial interests to detect potential conflict of interests. The agency evaluates “potentially disqualifying interests or relationships” before meetings and make changes to the rosters if needed, an FDA spokesperson told us in an email.
“For the VRBPAC meetings focused on the COVID-19 vaccine EUAs, the FDA screened and cleared all committee members and consultants for any relevant disqualifying interests or relationships, per our established standard practice, prior to their participation,” the FDA’s Abby Capobianco wrote.
What do they have to disclose?
VRBPAC members are also considered Special Government Employees, and therefore are required to file financial disclosure reports. But instead of filing OGE Form 450, members of FDA advisory committees use an alternate confidential financial disclosure report — FDA Form 3410 — which they have to file prior to each meeting.
The report asks members to disclose any involvement or financial link that they, their family, their employer or other organization they are associated with have with the products or issues to be discussed at the meeting. Those include current investments, employment or grants, and also past financial interests or other involvements. The FDA then reviews the reports to determine if there is any direct conflict of interest with the issues to be discussed in the meetings, or something that may create the “appearance” of a lack of impartiality.
If the FDA determines there is a “direct and predictable effect” on a member’s financial interests, he or she will not be able to serve on the FDA advisory committee for that matter. The FDA can grant the member an exception or a waiver to serve on the advisory committee if the FDA determines the conflicts of interests “are too remote or too inconsequential to affect the integrity of the services” or if the need for the member’s services “outweighs the potential for a conflict of interest.”
Is it publicly available?
No, the reports are confidential.
What about royalties?
FDA Form 3410 requires members to disclose patents, royalties and trademarks and indicate if they are related to the products, indications or issues to be discussed at the upcoming meeting. If they are related, the member is required to indicate the income received. The FDA then reviews the information for conflicts of interest, as we described above.